A traditional Chinese medicine composition for treating diabetic nephropathy and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating diabetic nephropathy and application thereof, and belongs to the technical field of traditional Chinese medicine, and is composed of the following components by weight percentage: 10-20 parts of poria cocos, 10-20 parts of atractylodes, 5-15 parts of curcuma zedoary, 10-20 parts of motherwort, and 3-10 parts of safflower; the application further discloses a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition has the following beneficial effects: the curcuma zedoary is used as a monarch drug and has the functions of promoting blood circulation and removing blood stasis and eliminating accumulation; the motherwort is used to remove water and swelling and activate blood and regulate menstruation, which can help the curcuma zedoary to remove blood stasis and eliminate accumulation, remove water and remove dampness, and expel evil, and the safflower is used with the curcuma zedoary to increase the effects of activating blood and removing blood stasis, and all of them are used as minister drugs; the poria cocos and the atractylodes are used to remove water and dampness, activate blood and regulate menstruation, and remove blood stasis and eliminate accumulation, which can help the curcuma zedoary to remove blood stasis and eliminate accumulation, remove water and remove dampness, and expel evil, and all of them are used as auxiliary drugs. The traditional Chinese medicine composition has the functions of activating blood, removing blood stasis, removing water and removing dampness.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating diabetic nephropathy and application thereof. BACKGROUND

[0002] Diabetic nephropathy is one of the main chronic complications of diabetes, and is the primary cause of end-stage renal disease at present. It is mainly manifested as persistent proteinuria in clinic, and is mainly manifested as glomerular mesangial area widening and glomerular capillary basement membrane thickening in pathology. Both type 1 and type 2 diabetes can develop diabetic nephropathy, and the prognosis is relatively poor, and it often progresses to renal insufficiency and uremia relatively quickly.

[0003] Mogensen divides diabetic nephropathy into five stages: stage I, glomerular hyperfiltration; stage II, normal albuminuria; stage III, microalbuminuria (early stage); stage IV, clinical proteinuria (middle stage); and stage V, renal failure (late stage). Stages I and II are mainly manifested as changes in renal hemodynamics and slight pathological changes, and have no specific clinical manifestations, and there is no special treatment, mainly strengthening the treatment of the primary disease diabetes and the control of inducing factors such as hyperlipidemia and hypertension. After entering stage III, it is mainly manifested as characteristic nodular glomerulosclerosis in pathology. In stages III and IV, it is mainly manifested as proteinuria (microalbuminuria, clinical proteinuria, massive proteinuria) and early and middle stage renal failure, and the treatment mainly focuses on controlling proteinuria by ACEI / ARB and symptomatic treatment. In stage V, it is mainly manifested as end-stage renal failure and multiple system complications, and the treatment mainly focuses on dialysis, kidney transplantation and symptomatic treatment for multiple system complications.

[0004] The main treatment of diabetic nephropathy in Western medicine is to control blood pressure, blood sugar and blood lipid, and although there is certain benefit in clinic, Western medicine is inevitably metabolized by the kidney, which aggravates the toxicity of the kidney, and long-term application is costly and ineffective. Diabetic nephropathy belongs to the category of “consumptive diabetes nephropathy” in traditional Chinese medicine, and traditional Chinese medicine scholars generally believe that its pathology is blood stasis, water and dampness and turbidity, and the treatment mainly selects traditional Chinese medicines with the effects of removing dampness, promoting blood circulation and removing blood stasis. However, most traditional Chinese medicine compounds are limited to single syndrome type, and the range of treatment objects is narrow, which is difficult to popularize, especially the effective prescription for the early stage of diabetic nephropathy still needs to be studied.

[0005] In view of this, the present inventors carried out in-depth research in view of this demand, and thus the present application was produced. SUMMARY

[0006] In order to solve the above problems, the present inventors have obtained a traditional Chinese medicine composition for treating diabetic nephropathy and application thereof through strict design of animal experiments and clinical research verification, which is widely applicable to the prevention and treatment of diabetic nephropathy, and has certain curative effect especially in the early stage of diabetic nephropathy.

[0007] The application provides a traditional Chinese medicine composition for treating diabetic nephropathy, which is composed of the following components by weight: 10-20 parts of poria cocos, 10-20 parts of atractylodes, 5-15 parts of curcuma, 10-20 parts of motherwort, and 3-10 parts of safflower.

[0008] Preferably, the traditional Chinese medicine composition is composed of the following components by weight: 12-18 parts of poria cocos, 12-18 parts of atractylodes, 7-13 parts of curcuma, 12-18 parts of motherwort, and 4-8 parts of safflower.

[0009] Preferably, the traditional Chinese medicine composition is composed of the following components by weight: 14-16 parts of poria cocos, 14-16 parts of atractylodes, 9-11 parts of curcuma, 14-16 parts of motherwort, and 5-6 parts of safflower.

[0010] Preferably, the traditional Chinese medicine composition is composed of the following components by weight: 14-16 parts of poria cocos, 14-16 parts of atractylodes, 9-11 parts of curcuma, 14-16 parts of motherwort, and 5-6 parts of safflower.

[0011] The application also provides use of the traditional Chinese medicine composition in preparation of a medicine for treating diabetic nephropathy, in particular, a medicine for treating early-stage diabetic nephropathy.

[0012] The application also provides a medicine for treating diabetic nephropathy, which is composed of the traditional Chinese medicine composition for treating diabetic nephropathy and pharmaceutically acceptable adjuvants.

[0013] Preferably, the medicine is in the form of a traditional Chinese medicine decoction, granules, pills, capsules, tablets, suspensions, powders, or oral liquids.

[0014] The application also provides a preparation method of the medicine for treating diabetic nephropathy, which is a traditional Chinese medicine decoction, and the preparation method is as follows:

[0015] Step one, the raw medicine is weighed according to the proportion by weight, and is treated by removing residual pesticides, removing sulfur, removing heavy metals, and mechanically crushing into coarse powder, and is uniformly mixed;

[0016] Step two, the raw medicine coarse powder is extracted;

[0017] Step three, the extract is collected, filtered by centrifugation, and concentrated, and the traditional Chinese medicine decoction is obtained.

[0018] Preferably, the raw medicine coarse powder is extracted by using a high-efficiency high-pressure continuous extraction technology in step two, a flow phase is water, the extraction is continuously carried out twice at a high-pressure difference of 0.1-35 MPa and a time of 0.2 seconds under the condition of 10-40 ℃, and the filtrates of the two times of extraction are combined.

[0019] Preferably, the extract is filtered twice in step three, and is preliminarily filtered by using a 200-mesh fiber filter screen, and is filtered by using a 500-nm ceramic membrane filter.

[0020] The beneficial effects of the technical scheme of the present application are as follows:

[0021] In the traditional Chinese medicine composition, zedoary is the monarch drug, which has the functions of promoting blood circulation and removing blood stasis and resolving accumulation, and is closely related to the basic pathogenesis of the disease; motherwort can benefit water and swelling, activate blood and regulate menstruation, which can help zedoary to remove blood stasis and resolve accumulation, and also can benefit water and remove dampness, expel evil from the body, and red safflower is combined with zedoary to enhance the effect of activating blood and removing blood stasis, and both of them are the ministerial drugs; fuzilu can benefit water and remove dampness, and atractylodes can benefit spleen and qi, dry dampness and benefit water, so that the spleen qi is operated normally, and the water and liquid are transported normally, and both of them are the auxiliary drugs. The combination of the above drugs can activate blood, remove blood stasis and benefit water.

[0022] The prescription composition of the present application is reasonable, does not contain toxic medicinal materials, and has no compatibility contraindication, and has the effects of reducing urinary protein and delaying the progression of diabetic nephropathy, especially for patients in the third stage of diabetic nephropathy, can effectively improve the blood glucose and blood lipid conditions of patients, and has significant curative effect. Previous studies have shown that zedoary has significant effects on liver fibrosis and renal interstitial fibrosis. The effective active ingredient of motherwort, kaempferol, can inhibit the inflammatory response mediated by Rho A / Rho kinase activation in renal tubular cells, reduce the expression of TNF-α and IL-1β and other pro-inflammatory factors, thereby delaying the progression of kidney disease. Fuzilu polysaccharide can also reduce inflammation and reduce renal inflammation. The raw materials are all natural soothing ingredients, the drug effect is mild, safe and reasonable, the process is simple, the clinical curative effect is reliable, no obvious toxic side effects and adverse reactions occur during application, the clinical curative effect is ensured, and the quality is controllable. The whole prescription medicine is refined, the price is low, and has good application prospect and market prospect. DETAILED DESCRIPTION

[0023] In order to make the purpose, technical scheme and advantages of the embodiments of the present application more clear, the technical scheme in the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. Therefore, the following detailed description of the embodiments provided by the present application is not intended to limit the scope of the claimed application, but only represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0024] The inventor has obtained a traditional Chinese medicine composition for treating diabetic nephropathy and a preparation method and application thereof through strictly designed animal experiments and clinical research verification, which is widely applicable to the prevention and treatment of diabetic nephropathy, and has certain curative effect especially in the early stage of diabetic nephropathy. The specific implementation is as follows:

[0025] The application provides a traditional Chinese medicine composition for treating diabetic nephropathy, which is composed of the following components by weight: 10-20 parts of poria cocos, 10-20 parts of atractylodes, 5-15 parts of curcuma zedoary, 10-20 parts of motherwort, and 3-10 parts of safflower.

[0026] As a preferred embodiment, the traditional Chinese medicine composition is composed of the following components by weight: 12-18 parts of poria cocos, 12-18 parts of atractylodes, 7-13 parts of curcuma zedoary, 12-18 parts of motherwort, and 4-8 parts of safflower.

[0027] As a preferred embodiment, the traditional Chinese medicine composition is composed of the following components by weight: 14-16 parts of poria cocos, 14-16 parts of atractylodes, 9-11 parts of curcuma zedoary, 14-16 parts of motherwort, and 5-6 parts of safflower.

[0028] As a preferred embodiment, the traditional Chinese medicine composition is composed of the following components by weight: 14-16 parts of poria cocos, 14-16 parts of atractylodes, 9-11 parts of curcuma zedoary, 14-16 parts of motherwort, and 5-6 parts of safflower.

[0029] The application also provides the use of the traditional Chinese medicine composition in the preparation of a medicine for treating diabetic nephropathy, in particular, a medicine for treating early-stage diabetic nephropathy.

[0030] The application also provides a medicine for treating diabetic nephropathy, which is composed of the traditional Chinese medicine composition for treating diabetic nephropathy and pharmaceutically acceptable excipients.

[0031] As a preferred embodiment, the dosage form of the medicine is a traditional Chinese medicine decoction, granules, pills, capsules, tablets, suspensions, powders or oral liquids.

[0032] The application also provides a preparation method of the medicine for treating diabetic nephropathy, which is a traditional Chinese medicine decoction, and the preparation method is as follows:

[0033] Step one, the raw medicine is weighed according to the proportion by weight, and is treated by removing residual pesticides, removing sulfur and removing heavy metals, and is mechanically crushed into coarse powder and mixed uniformly;

[0034] Step two, the raw medicine coarse powder is extracted;

[0035] Step three, the extract is collected, centrifuged and filtered, and then is concentrated.

[0036] Preferably, the raw medicine coarse powder is extracted in step two by using a high-efficiency high-pressure continuous extraction technology, the mobile phase is water, the high-pressure difference is 0.1-35 MPa at a temperature of 10-40 DEG C, the continuous extraction time is 0.2 seconds, and the extraction is performed twice, and the filtrates of the two times of extraction are combined.

[0037] As a preferred embodiment, the extract in step three needs to be filtered twice, first with a 200 mesh fiber filter screen, and then with a 500 nm ceramic membrane filter.

[0038] The application will be further described in detail below with reference to the specific embodiments: Embodiment

[0039] A medicine for treating diabetic nephropathy, the raw medicine of which comprises: 10 parts of Poria cocos, 10 parts of Atractylodes, 5 parts of Curcuma, 10 parts of Motherwort, and 10 parts of Safflower. The preparation method of the medicinal decoction comprises the following steps:

[0040] Step one, the above-mentioned raw medicine 100 kg is weighed according to the weight ratio, and is treated by removing residual pesticides, removing sulfur, removing heavy metals, mechanically crushing into coarse powder, and mixing uniformly;

[0041] Step two, the raw medicine coarse powder is extracted by using high-efficiency high-pressure continuous extraction technology, 1500 mL of water is added to the coarse powder, and the extraction is carried out once at a high pressure difference of 0.1~35 MPa, and then centrifuged to collect the extract. The obtained residue is extracted again by the same method, and the extract filtrates obtained in two times are combined;

[0042] Step three, the extract is collected, first filtered with a 200 mesh fiber filter screen, and then filtered with a 500 nm ceramic membrane filter. The filtrate is concentrated by reverse osmosis to obtain a reverse osmosis concentrated liquid of about 30~40 kg, and the concentrated liquid of the embodiment is obtained. Embodiment

[0043] A medicine for treating diabetic nephropathy, the raw medicine of which comprises: 10 parts of Poria cocos, 10 parts of Atractylodes, 5 parts of Curcuma, 10 parts of Motherwort, and 10 parts of Safflower. The preparation method of the medicinal decoction comprises the following steps: Embodiment

[0044] A medicine for treating diabetic nephropathy, the raw medicine of which comprises: 10 parts of Poria cocos, 10 parts of Atractylodes, 5 parts of Curcuma, 10 parts of Motherwort, and 10 parts of Safflower. The preparation method of the medicinal decoction comprises the following steps: Embodiment

[0045] A medicine for treating diabetic nephropathy, the raw medicine of which comprises: 10 parts of Poria cocos, 10 parts of Atractylodes, 5 parts of Curcuma, 10 parts of Motherwort, and 10 parts of Safflower. The preparation method of the medicinal decoction comprises the following steps:

[0046] The concentrated liquid prepared in the above-mentioned embodiments 1-4 is diluted with water to obtain the maximum concentration, and the mice are given the maximum concentration and the maximum gavage volume once per 24 hours, and then the toxic reactions and death of the animals are observed.

[0047] 1. Test materials

[0048] 1.1 Medicine

[0049] The maximum concentrations of the concentrated Chinese medicine compositions prepared in Example 1, Example 2, Example 3 and Example 4, respectively, are 2.25 g crude drug / mL, 2.77 g crude drug / mL, 3.01 g crude drug / mL and 3.25 g crude drug / mL, respectively, after dilution with water.

[0050] 1.2 Animals

[0051] Kunming mice, clean grade, half male and half female, weighing 18-22 g, were provided by the Guangdong Experimental Animal Center. The mice were acclimated for 7 days in an observation room with a temperature of 18-25℃ and humidity of 50-60% before the experiment, and the observation room was disinfected with sterilized sawdust once a day, sterilized with ultraviolet light once a day, and ventilated twice a day in the morning and evening.

[0052] Experimental animal environment: clean grade environment.

[0053] 2. Test method

[0054] 2.1 Pre-test

[0055] The mice were fasted for 12 hours without water, and were randomly divided into 4 groups according to gender and body weight, with 6 mice in each group. The 4 groups of Example 1, 2, 3 and 4 were administered by gavage at the above maximum concentration with a dose of 0.4 mL / 10 g of body weight at one time, and were continuously observed for 5 days. The LD100 value (100% mortality rate), the LD0 value (0% mortality rate and the corresponding dose group value), and the life status of the mice were found during the period. No death was observed. Since the LD50 of the drug could not be measured, the maximum tolerated dose (MTD) was determined.

[0056] 2.2 Formal experiment (maximum tolerated dose determination)

[0057] According to the results of the pre-test, since the LD50 could not be measured, the maximum tolerated dose was determined. 100 mice, half male and half female, were randomly divided into 5 groups, namely a blank control group and Example 1, 2, 3 and 4 groups, with 20 mice in each group, half male and half female. The mice were fasted for 12 hours without water, and the 4 groups of Example 1, 2, 3 and 4 were administered by gavage at the above maximum concentration with a dose of 0.4 mL / 10 g of body weight at one time. The blank control group was given distilled water. The mice were continuously observed for 14 days after administration, and the poisoning performance and symptoms (see Table 1), body weight and death were recorded. If a mouse died, the dead mouse was dissected, and the changes in the heart, liver, spleen, lung, kidney, adrenal gland, thymus, stomach, testis, prostate, uterus, ovary and other organs were observed macroscopically. After the 14-day observation period, the surviving mice in each group were sacrificed for dissection, and the macroscopic observation of the general pathological changes of the main organs was performed according to the same method as above. The wet weight of each organ was measured, and the organ index [organ weight (mg) / body weight (g)] was calculated.

[0058] Table 1 Observation items of mice

[0059]

[0060]

[0061] 3. Test Results

[0062] 3.1 Toxic Symptoms of Mice

[0063] Blank Control Group: The mice were active and normal in response during the observation period of 1-14 days. The fur was lustrous, the skin color was normal, the diet and excretion were normal, and the mice grew normally without any abnormal state.

[0064] Dosing Group: After 15-60 minutes of administration, some mice were less active, and the diet and water intake were reduced. However, no animal showed the symptoms of writhing, trembling, staggering, and instability, and no symptoms such as diarrhea, constipation, intestinal distension, etc. occurred. After 1-2 hours, the mice moved more and were more active, and climbed in the cage and sniffed food and water. After 3-4 hours, the mice returned to normal. During the observation period of 14 days thereafter, the mice were active and normal in response, the fur was lustrous, the skin color was normal, the diet and excretion were normal, and no abnormal state was observed.

[0065] 3.2 Death of Mice

[0066] From the time of administration to the observation period of 14 days, all mice in the blank control group and the dosing group survived, and no mouse died in each group.

[0067] 3.3 Changes in Body Weight of Mice

[0068] Blank Control Group: The mice had normal weight gain.

[0069] Dosing Group: The mice had normal weight gain, and there was no significant difference compared with the control group (see Table 2).

[0070] Table 2 Effects on Body Weight of Mice

[0071]

[0072] 3.4 Autopsy and Organ Index

[0073] After the end of the experiment, all mice in each group were sacrificed by cervical dislocation, and the internal organs and organs of the mice were observed macroscopically. The results showed that the color and texture of the heart, liver, spleen, lung, kidney, adrenal gland, thymus, stomach, testis, prostate, uterus, ovary, and other organs were normal. As shown in Table 2, the wet weight of the above organs was taken, and the organ index [organ weight (mg) / body weight (g)] was calculated. There was no significant difference in the organ index of mice in Example 1, 2, 3, and 4 compared with the blank control group.

[0074] Thus, the above-mentioned embodiments 1, 2, 3, and 4 do not show obvious acute toxicity when administered to animals, and the results show that the embodiments 1, 2, 3, and 4 are basically safe and non-toxic in a large dose, and the administration is safe in a clinical dose.

[0075] The prepared traditional Chinese medicine compositions of the above-mentioned four embodiments are administered to mice once every 24 hours, and the efficacy test on diabetic nephropathy is observed.

[0076] 1. Materials and methods

[0077] 1.1 Experimental animals

[0078] SD rats, male, weighing 250±50g, 140, provided by the Guangdong Provincial Animal Experimental Animal Center.

[0079] 1.2 Drugs and reagents

[0080] The traditional Chinese medicine prescriptions in embodiments 1, 2, 3, and 4; dapagliflozin tablets; streptozotocin (STZ); coomassie blue; biochemical test reagents, etc.

[0081] 1.3 Instruments

[0082] DFM-96 type 16-tube radioimmunoassay analyzer; semi-automatic biochemical analyzer; LG-R-80 series blood viscosity tester; LG-B-190 type cell rheology tester; DV990 enzyme label instrument; optical microscope; transmission electron microscope; metabolic cage; balance, etc.

[0083] 2. Experiment and method

[0084] Modeling: 120 SD rats weighing 250±50g were selected, weighed before the experiment, and after fasting for 12 hours, modeling was performed by intraperitoneal injection of STZ citric acid buffer solution at a dose of 64mg / kg body weight. 72 hours after modeling, the blood glucose was measured, and animals with blood glucose values of 13.8-25mmol after modeling were selected for the experiment.

[0085] Grouping: the animals after modeling were divided into a model control group, a positive drug control group, embodiments 1, 2, 3, and 4, 20 in each group, and a normal control group of 20 was also set. The animals were administered once a day for 6 weeks, and embodiments 1, 2, 3, and 4 were administered at a dose of 10mL / kg body weight, the positive drug control group was administered dapagliflozin dissolved in distilled water at a dose of 10mg / kg body weight, and the model control group was administered distilled water. The normal control group was not modeled and administered distilled water.

[0086] Indicators: 24-hour urine was collected at 3, 5, 7, 10, 12 weeks after modeling, and 24-hour urine volume and 24-hour urine protein total amount were measured. The animals were dissected at 3, 7, 12 weeks after administration to observe the following indicators: body weight, blood glucose, blood creatinine, and urine protein.

[0087] Table 3 Effects on blood creatinine of diabetic nephropathy rats

[0088]

[0089]

[0090] Compared with the model control group b P<0.05, c P<0.01

[0091] Compared with the normal control group a P<0.01

[0092] Table 4 Effects on 24-hour urine protein total amount of diabetic nephropathy rats

[0093]

[0094] Compared with the model control group b P<0.05, c P<0.01

[0095] Compared with the normal control group a P<0.01

[0096] Table 5 Effects on body weight of diabetic nephropathy rats

[0097]

[0098]

[0099] Compared with the model control group b P<0.05, c P<0.01

[0100] Compared with the normal control group a P<0.01

[0101] Table 6 Effects on blood glucose of diabetic nephropathy rats

[0102]

[0103] Compared with the model control group b P<0.05, c P<0.01

[0104] Compared with the normal control group a P<0.01

[0105] From Table 3-6, it can be seen that from the 3rd week of administration, the blood creatinine, urine protein and blood glucose of the model control group were significantly increased compared with the normal control group, and the body weight was lower than that of the normal control group, while the urine protein of the administration groups of Examples 1, 2, 3 and 4 was significantly reduced compared with the model control group, and there was no great difference in body weight, blood creatinine, urine protein and blood glucose between the administration groups and the positive drug control group.

[0106] From the 7th week of administration, the blood creatinine, urine protein and blood glucose of the model control group were increased compared with the 3rd week, and the body weight was also reduced, while the indicators of the administration groups of Examples 1, 2, 3 and 4 were still close to the positive drug control group, and the blood creatinine, urine protein and blood glucose were lower than the data of the model control group. From the 12th week of administration, the blood creatinine, body weight and blood glucose of the model control group were increased compared with the 7th week, and the blood creatinine was reduced, and the indicators of the administration groups of Examples 1, 2, 3 and 4 were still close to the positive drug control group. From the above results, it can be seen that the above-mentioned Examples 1, 2, 3 and 4 can significantly improve the blood creatinine and urine protein levels of diabetic nephropathy rats, and to a certain extent, can delay the pathological changes of kidney tissue, and have a protective effect on the kidney.

[0107] Next, the clinical efficacy experiment of the traditional Chinese medicine drug prepared in Preferred Example 3 on diabetic nephropathy patients is observed.

[0108] 1. Case source situation

[0109] The study population was patients with diabetic nephropathy G3A3, who met the diagnostic criteria and inclusion criteria, and patients who did not meet the criteria were excluded, and finally 30 patients were randomly assigned, of which 15 patients in the treatment group and 15 patients in the control group were treated with dapagliflozin tablets (10 mg / tablet) as the basis, one tablet each time, one tablet per day, 4 weeks as a course of treatment, a total of 3 courses. On this basis, the traditional Chinese medicine drug of Example 3 was given to the treatment group, equivalent to 12g of crude drug each time, twice a day, 4 weeks as a course of treatment, a total of 3 courses, and at the same time, the control group was given a simulated agent without efficacy. During the trial, 0 cases of dropouts were observed, and finally 30 cases were completed.

[0110] 2. Efficacy observation

[0111] 2.1 Comparison of overall efficacy between the two groups (see Table 7)

[0112] According to the assessment of "Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine", the following criteria are used: significant effect: clinical symptoms improve or disappear, TCM syndrome score decreases by 50% or more, symptoms disappear or significantly improve; effective: symptoms improve, score decreases by 30%-49%; ineffective: no improvement or worsening, score decreases by less than 30%. The total effective rate = (number of cases with significant effect + number of cases with effective) / total number of cases x 100%. The total effective rate of the treatment group was 86.7%, and the effective rate of the control group was 66.7%.

[0113] Table 7 Comparison of curative effects of two groups before and after treatment

[0114]

[0115] 2.2 Comparison of renal function of two groups before and after treatment (see Table 8)

[0116] Table 8 Serum creatinine, glomerular filtration rate and urea nitrogen levels of two groups before and after treatment

[0117]

[0118] Compared with the same group before treatment, a P<0.05, compared with the control group after treatment, b P<0.05.

[0119] 2.3 Comparison of 24h urine protein of two groups before and after treatment (see Table 9)

[0120] Table 9 24h urine protein levels of two groups before and after treatment

[0121]

[0122] As can be seen from Tables 7-9, both the treatment group and the control group use dapagliflozin tablets as the basis for treatment, and the overall efficacy, renal function, and 24h urine protein of the treatment group are better than those of the control group, which can significantly reduce the serum creatinine and urine protein levels of patients with diabetic nephropathy and improve the clinical symptoms of patients.

[0123] The above only describes the preferred embodiments of the present application and is not intended to limit the present application. For those skilled in the art, the present application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating diabetic nephropathy, characterized in that, By weight parts, consisting of the following raw material components: 10~20 parts of poria, 10~20 parts of atractylodes, 5~15 parts of zedoary, 10~20 parts of motherwort, 3~10 parts of safflower.

2. The traditional Chinese medicine composition for treating diabetic nephropathy according to claim 1, characterized in that, By weight parts, consisting of the following raw material components: 12~18 parts of poria, 12~18 parts of atractylodes, 7~13 parts of zedoary, 12~18 parts of motherwort, 4~8 parts of safflower.

3. The Chinese medicine composition for treating diabetic nephropathy according to claim 1, characterized in that, By weight parts, consisting of the following raw material components: 14~16 parts of poria, 14~16 parts of atractylodes, 9~11 parts of zedoary, 14~16 parts of motherwort, 5~6 parts of safflower.

4. The use of the traditional Chinese medicine composition for treating diabetic nephropathy according to any one of claims 1-3 in the preparation of a medicine for treating diabetic nephropathy.

5. A medicament for treating diabetic nephropathy, characterized by, The traditional Chinese medicine composition for treating diabetic nephropathy according to any one of claims 1-3 and a pharmaceutically acceptable excipient.

6. The medicament for treating diabetic nephropathy according to claim 5, wherein The dosage form of the medicine is traditional Chinese medicine decoction, granules, pills, capsules, tablets, suspensions, powders or oral liquids.

7. The method of preparing a medicament for treating diabetic nephropathy according to claim 5 or 6, characterized in that, The medicine is a traditional Chinese medicine decoction, and the preparation method is as follows: Step one, the raw material is weighed according to the weight ratio, and after the residual pesticide, sulfur and heavy metal treatment, it is mechanically crushed into coarse powder and mixed uniformly; Step two, the raw material coarse powder is extracted; Step three, the extract is collected, filtered and concentrated, and the traditional Chinese medicine decoction is obtained.

8. The method of claim 7, wherein, In step two, the raw material coarse powder is extracted by high-efficiency high-pressure continuous extraction technology, the mobile phase is water, the high-pressure difference is 0.1-35 MPa at 10-40℃, the time is 0.2 seconds, and the two times of extraction filtrate are combined.

9. The preparation method according to claim 7, characterized in that, In step three, the extract needs to be filtered twice, first using a 200 mesh fiber filter screen for preliminary filtration, and then using a 500 nm ceramic membrane filter for filtration.

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